Table 6.
Common adverse events (reported in at least 10 % of patients in total)
| MedDRA, version 14.1, preferred term | All adverse events | Adverse events considered to be related to study drug | ||||
|---|---|---|---|---|---|---|
| Phase I (N = 9) | Phase II (N = 38) | Total (N = 47) | Phase I (N = 9) | Phase II (N = 38) | Total (N = 47) | |
| Overall | 9 (100.0) | 36 (94.7) | 45 (95.7) | 7 (77.8) | 24 (63.2) | 31 (66.0) |
| Weight decreased | 1 (11.1) | 16 (42.1) | 17 (36.2) | 0 | 5 (13.2) | 5 (10.6) |
| Decreased appetite | 3 (33.3) | 10 (26.3) | 13 (27.7) | 2 (22.2) | 4 (10.5) | 6 (12.8) |
| Constipation | 2 (22.2) | 10 (26.3) | 12 (25.5) | 1 (11.1) | 6 (15.8) | 7 (14.9) |
| Hypertension | 3 (33.3) | 6 (15.8) | 9 (19.1) | 3 (33.3) | 4 (10.5) | 7 (14.9) |
| Cancer pain | 1 (11.1) | 8 (21.1) | 9 (19.1) | 0 | 1 (2.6) | 1 (2.1) |
| Nausea | 4 (44.4) | 5 (13.2) | 9 (19.1) | 1 (11.1) | 2 (5.3) | 3 (6.4) |
| Electrocardiogram QT prolonged | 0 | 6 (15.8) | 6 (12.8) | 0 | 5 (13.2) | 5 (10.6) |
| Fatigue | 2 (22.2) | 4 (10.5) | 6 (12.8) | 2 (22.2) | 4 (10.5) | 6 (12.8) |
| Nasopharyngitis | 1 (11.1) | 5 (13.2) | 6 (12.8) | 0 | 0 | 0 |
| Pyrexia | 1 (11.1) | 4 (10.5) | 5 (10.6) | 1 (11.1) | 0 | 1 (2.1) |
| Somnolence | 0 | 5 (13.2) | 5 (10.6) | 0 | 1 (2.6) | 1 (2.1) |
| Rash | 0 | 5 (13.2) | 5 (10.6) | 0 | 1 (2.6) | 1 (2.1) |
Number of patients (%)
MedDRA Medical Dictionary for Regulatory Activities